MAUDE MDR 3775171

MDR report key
3775171
Report number
3775171
Event key
0
Event type
3
Date of event
2014-03-28
Date received
2014-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTELECTSTIMULATOR, ULTRASOUND AND MUSCLEDJO, LLCIPF2738** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-040

Event Narratives#

D

Patient 1

THE PATIENT HAD RECEIVED ELECTRICAL STIMULATION TO LEFT SHOULDER WITH A CERVICAL HOT PACK PLACED ON THE UPPER TRAPEZIUS REGION. ELECTRICAL STIMULATION WAS TURNED UP TO A COMFORTABLE LEVEL PER PATIENT REPORTS AND NO MUSCLE TWITCHING WAS NOTED. THE PATIENT RETURNED FIVE DAYS LATER AND POINTED TO LATERAL DELTOID AND 3 WOUNDS WERE NOTED WITH THE LARGEST MEASURING 2CM X 1CM. ALL WOUNDS WERE CLEAN, CLOSED, WITH SCABBING NOTED AND NO DRAINAGE. THE LARGEST WOUND WAS NOTED TO HAVE CLEAN AND WELL DEFINED MARGINS WITH THE SCABBING NOTED MORE MEDIALLY. MARGINS APPEARED PINK AND NOT RED IN COLOR. NO WOUNDS WERE NOTED WHERE OTHER ELECTRODES WERE PLACED (LEFT UPPER TRAPEZIUS, ANTERIOR DELTOID UNDER INCISIONS FROM SURGERY, AND POSTERIOR DELTOID). THE PATIENT STATED THAT HE HAD FORGOTTEN THAT HIS WIFE HAD USED A MUSCLE RUB ON HIS SHOULDER AND HE FORGOT TO INFORM US. PATIENT WAS ASKED IF HE SAID ANYTHING TO THE REHAB TECHNICIAN WHO TOOK HIM OFF OF THE MACHINE. HE SAID HE HAD NOT REPORTED ANYTHING OR USED THE BUZZER (GIVEN INSTRUCTIONS TO USE IN PAIN OR DISCOMFORT FOR ANY REASON) BECAUSE HE SAID HE REALIZED IT LATER. PATIENT WAS ASKED IF HE HAD ANY SIGNIFICANT DISCOMFORT WHILE THE ELECTRODES WERE ON HIM AND HE SAID HE THOUGHT IT WAS A HOT PACK. HE STATED HIS WIFE NOTED THE BURNS ON HIS ARM WHEN HE RETURNED HOME. THE PATIENT STATED THAT HIS WIFE HAD USED A MUSCLE RUB ON HIM PRIOR TO COMING FOR TREATMENT.